| Table 4. Pharmacodinamic endpoints (per-protocol population). | ||||
| r-hFSH biosimilar >n=45 |
original α r-hFSH >n=41 |
Difference | ||
|---|---|---|---|---|
| Number of follicles within 14.1 to 16 mm - Mean (SD); Range | 2.8 (2.3); 0-9 | 2.9 (2.0); 0-9 | -0.1 | 0.947* |
| Number of follicles >16 mm - Mean (SD); Range | 6.0 (3.3); 2-16 | 5.8 (2.8); 2-14 | 0.2 | 0.746* |
| E2 levels - Mean (SD); Range | 1927 (1420); 341-6065 | 1949 (1294); 619-7250 | -22 | 0.941* |
| Number of metaphase II oocytes - Mean (SD); Range | 8.9 (6.1); 1-29 | 9.7 (5.3); 3-24 | -0.8 | 0.486* |
| Number of good quality oocytes - Mean (SD); Range | 4.7 (6.1); 0-29 | 4.7 (4.5); 0-18 | 0.0 | 0.972* |
*Student's t-test
SD=Standard Deviation